INTRODUCTION
Good manufacturing practices require that objectionable organisms be absent from nonsterile dietary products. A microorganism can be considered objectionable if it represents a potential health hazard to the user, who is using the product as directed, or if the microorganism is capable of growing in the product. Objectionable microorganisms are defined as contaminants that—depending on the microbial species, number of organisms, dosage form, intended use, and patient population—would adversely affect product safety. Additionally, microorganisms may be deemed objectionable if they adversely affect product stability or if they may damage the integrity of the container closure system.
This chapter describes the testing of dietary articles for specified microorganisms that are included in the individual monographs or whose absence is recommended by the guidance under Microbiological Attributes of Nonsterile Nutritional and Dietary Supplements 〈2023〉. When individual monographs do not specify objectionable microorganisms, it is the manufacturers' responsibility to determine which microorganisms in their products are objectionable. It is not intended that all nonsterile dietary articles be tested for the absence of all the microorganisms mentioned in this chapter, nor is the testing of relevant microorganisms restricted to those presented in this chapter.
Alternative methods may be substituted for the tests, provided that they have been properly validated as giving comparable results, General Notices 6.30. See Validation of Alternative Microbiological Methods 〈1223〉 for general guidance.
BUFFER AND MEDIA
General Considerations
See Microbial Enumeration Tests—Dietary Ingredients and Dietary Supplements 〈2021〉, Buffer Solution and Media. The appropriateness of each medium for the intended purpose is to be assessed. Control sets of Fluid Soybean–Casein Digest Medium (FSCD) for method suitability are also used to assess the appropriateness of these media in the growth promotion of the specified microorganisms. For other media, streak agar plates to obtain isolated colonies of appropriate microorganisms and inoculate the fluid media with the appropriate microorganisms at a final concentration of not more than 100 CFU/mL. Observe the growth to establish the appropriateness of the media.
Buffer
buffer stock solution and pH 7.2 phosphate buffer
Proceed as directed in 〈2021〉.
Media
Prepare media for the tests as described in 〈2021〉, Appendix. Alternatively, dehydrated formulations may be used provided that, when reconstituted as directed by the manufacturer or distributor, they meet the requirements of 〈2021〉, Growth-promotion testing. Unless otherwise indicated elsewhere in this chapter, media are sterilized in autoclaves using a validated process. The exposure time within the autoclave at 121° will depend on the volume of media to be sterilized. Thus, for example, a 500-mL volume would need to be autoclaved using a temperature and time relationship that will ensure the medium has attained at least an F0 value of 12–15 in the sterilization process, where F0 represents the equivalent sterilization time in minutes at 121° needed for microbial lethality. However, the appropriate time and temperature duration for sterilizing prepared media at any given volume and autoclave load should be confirmed by a thermal penetration study using a thermocouple or thermoprobe placed within the liquid medium. Avoid excessive heating that may reduce the media's growth-promoting capacity.
METHOD SUITABILITY
For enrichment broth, selective media, and differential media, use an inoculating loop to transfer the inoculum of each test organism to the plated or liquid media being tested. If a plated medium is being tested, streak the surface of plate with the loop in four directions to obtain a pattern of isolated colonies. Incubate the media, and examine the plated or liquid media for the characteristic growth of the inoculum (see Tables 2, 3, 4, and 5).
Source from USP and Please refer to USP for details:https://online.uspnf.com/uspnf/document/2_GUID-3F2C12E1-3BB4-4B49-A249-29EED03EC621_20201_en-US?source=TOC
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